What is NDC 65197-204?

65197-204 is the product NDC for Emetrol Chewables (sodium citrate dihydrate), Trisodium citrate dihydrate 230 mg/1 tablet, chewable, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Emetrol Chewables (Sodium citrate dihydrate).

WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Emetrol Chewables?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Emetrol Chewables NDC 65197-204 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65197-204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65197-0204Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65197-204-42	6519702044265197020442	1 BOTTLE in 1 BOX (65197-204-42) / 42 TABLET, CHEWABLE in 1 BOTTLEMarketed from Mar 15, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Emetrol Chewables
Generic name (nonproprietary): sodium citrate dihydrate
Active ingredients: Trisodium citrate dihydrate — 230 mg/1
Dosage form: Tablet, Chewable
Route: Oral
Labeler: WellSpring Pharmaceutical CorporationNDC labeler code 65197
Product type: Over-the-counter drug
Marketing category: Unapproved drug (other)
Marketing start: Mar 15, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 65197-204_ddbf3d94-678a-4c09-b678-74de8cfa01b5SPL ID ddbf3d94-678a-4c09-b678-74de8cfa01b5
Pharmacologic class: Anti-coagulant; Calculi Dissolution Agent

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N465197020442 followed by a unit qualifier and the quantity

Package 65197-0204-42. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 65197-204

What is NDC 65197-204?: 65197-204 is the product NDC for Emetrol Chewables (sodium citrate dihydrate), Trisodium citrate dihydrate 230 mg/1 tablet, chewable, listed with the FDA by WellSpring Pharmaceutical Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Emetrol Chewables (Sodium citrate dihydrate).
What is the active ingredient?: Trisodium citrate dihydrate.
Who is the labeler?: WellSpring Pharmaceutical Corporation, NDC labeler code 65197. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Emetrol Chewables?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Emetrol Chewables (Sodium citrate dihydrate) NDC 65197-204